1690 Temporary scheduling of substance; carfentanil as a Schedule II controlled substance

Temporary Scheduling of Substance: Carfentanil as a Schedule II Controlled Substance

[46 Pa.B. 6194]
[Saturday, October 1, 2016]

 The Secretary of Health (Secretary) of the Department of Health (Department) is issuing this notice of intent to issue a final notice to temporarily schedule the substance carfentanil, a narcotic substance, as a Schedule II controlled substance under The Controlled Substance, Drug, Device and Cosmetic Act (act) (35 P.S. §§ 780-101—780-144). The Secretary is taking this action because the scheduling of carfentanil in this Commonwealth on a temporary basis is necessary to avoid an imminent hazard to public safety.

 At the time of publication in the Pennsylvania Bulletin, the Secretary will transmit a copy of the proposed notice to the Attorney General under section 3(d)(4) of the act (35 P.S. § 780-103(d)(4)) for his review. The Attorney General shall, by law, have 30 days from receipt of the proposed notice to provide written comments to the Department, if any.

 Any formal order may not be issued before the expiration of 14 days after both:

 (i) The date of publication in the Pennsylvania Bulletin of this proposed notice of the intention to issue a final notice and the grounds upon which the order is to be issued.

 (ii) The date the Secretary transmitted the notice to the Attorney General.

Background

 The United States Drug Enforcement Administration (DEA) classified carfentanil as a Schedule II narcotic under the Federal Controlled Substance Act (CSA) (21 U.S.C.A. §§ 801—971) on October 28, 1988. The DEA determined that carfentanil has: (1) a high potential for abuse; (2) a currently accepted veterinary medical use in treatment in the United States; and (3) that abuse of carfentanil may lead to severe psychological or physical dependence. Because carfentanil has acceptable veterinary medical uses, the DEA classified it as a Schedule II narcotic substance. The DEA further found that carfentanil is an opiate as defined in section 102(18) of the CSA (21 U.S.C.A. § 802(18)) since it has an addiction-forming and addiction-sustaining liability similar to morphine. Finally, carfentanil is a narcotic since the definition of narcotic, as proved in section 102(17)(A) of the CSA includes: ''Opium, opinates, derivatives of opium and opiates.''

 In this Commonwealth, by contrast, carfentanil is not currently scheduled. The Commonwealth has recently seen increases in drug traffickers mixing carfentanil instead of morphine to cut heroin. Because of carfentanil's high potential for abuse—as well as it being 10,000 times more potent than morphine—it poses a substantial risk to the public. The Secretary recognizes that there are legitimate veterinarian uses for carfentanil, but that the United States Food and Drug Administration (FDA) has not approved carfentanil for any medical use by or treatment for humans. That carfentanil has a high potential for abuse, which may lead to severe psychological or physical dependence, has prompted the Secretary to schedule carfentanil as a Schedule II controlled substance on a temporary basis. In doing so, the Secretary is acting to protect the citizens of this Commonwealth and bring the Commonwealth into conformity with Federal law.

Legal Authority and Action

 Under section 3 of the act, the Secretary shall control all substances listed in Schedules I through V of the act. Under section 3(d) of the act, the Secretary is authorized to schedule any substance on a temporary basis to avoid an imminent hazard to public safety. When determining whether a substance poses an imminent hazard to public safety, the Secretary is required to consider: (1) the substance's history and current pattern of abuse; (2) the substance's scope, duration and significance of its abuse; (3) the risk to the public health; and (4) whether the substance is controlled under Federal law. When a substance is already controlled under Federal law, the Secretary is not required to take the remaining factors into consideration.

 In addition, the Secretary is authorized under section 3(d) of the act, to schedule on a temporary basis a substance under one of the schedules in section 4 of the act (35 P.S. § 780-104), regarding schedules of controlled substances, if the substance is not listed in any other schedule in section 4 of the act or 28 Pa. Code §§ 25.72 and 25.75 (relating to schedules of controlled substances; and paregoric) and if no exception or approval is in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 355). As previously noted, while the FDA has approved carfentanil for medical use in treating large animals, the FDA has not approved carfentanil for any medical use in treating humans.

 Because carfentanil is a Schedule II narcotic under the CSA, the Secretary has the authority to temporarily schedule carfentanil under the act. Although not required to do so in taking this action, the Secretary has considered: (1) the increased current use of carfentanil to cut heroin; (2) carfentanil's addictive nature; and (3) the fact that carfentanil is 10,000 times more potent than morphine. Accordingly, the Secretary determined that carfentanil is a dangerous hazard to public safety.

 To revise 28 Pa. Code § 25.72 to conform to any final notice issued by the Secretary under section 3(c) of the act to temporarily schedule carfentanil as a Schedule II controlled substance, the Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final rulemaking with proposed rulemaking omitted.

Accessibility

 Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact the Department of Health, Bureau of Community Program Licensure and Certification, Division of Home Health by means of the Drug, Device and Cosmetic Program, 132A Kline Plaza, Harrisburg, PA 17104, [phone], or for speech and/or hearing impaired persons V/TT [phone] or the Pennsylvania AT&T Relay Service at [phone].

KAREN M. MURPHY, PhD, RN, 
Secretary

[Pa.B. Doc. No. 16-1690. Filed for public inspection September 30, 2016, 9:00 a.m.]